The Committee's initial recommendation is that -
#1 the Government support and expand the collection of data, research and analysis regarding genetic testing and treatment in Australia, in line with recommendation 19-1 of the 2004 Australia Law Reform Commission Genes and Ingenuity report.That is a worthy but unremarkable recommendation covering activity that in practice, as distinct from rhetoric, hasn't attracted much enthusiasm from either the ALP or Coalition.
The Committee goes on to recommend that -
#2 the Government conduct a "public consultation and feasibility study regarding establishing a transparency register for patent applications and other measures to track the use of patents dealing with genes and genetic materials".A supplementary comment by Senators Cooney and Heffernan, the latter best known for the shameful slur against then High Court justice Michael Kirby, reads -
#3 the Senate refer the Patent Amendment (Human Genes and Biological Materials) Bill 2010 to the relevant Senate committee for inquiry and report.
#4 the Government provide a combined response addressing the Committee's inquiry into gene patents, the 2004 Genes and ingenuity report by the Australian Law Reform Commission (ALRC) on gene patenting, the review of patentable subject matter by the Australian Council on Intellectual Property (ACIP) and the review of Australia's patent system by IP Australia. The Committee recommends that the response be provided not later than mid-2011 or three months after the release of the findings of all reviews.
#5 at an "appropriate time following the release of the ACIP review of patentable subject matter and the IP Australia review of the patent system, the Community Affairs References Committee be tasked with inquiring into the Government's response to, and implementation of, the recommendations of those reviews, as well as the recommendations of the Committee's report on gene patents".
#6 the Patents Act 1990 be amended so that the test for obviousness in determining inventive step is that a claimed invention is obvious if it was 'obvious for the skilled person to try a suggested approach, alternative or method with a reasonable expectation of success'.
#7 the Patents Act 1990 (Cth) be amended to remove the limitation that 'common general knowledge' be confined to that existing in Australia at the time a patent application is lodged (that is, that 'common general knowledge' anywhere in the world be considered).
#8 the Patents Act 1990 (Cth) be amended to "remove the requirement that 'prior art information' for the purposes of determining inventive step must be that which could reasonably have been expected to be 'ascertained' (that is, that the 'prior art base' against which inventive step is assessed not be restricted to information that a skilled person in the relevant field would have actually looked for and found)".
#9 the Patents Act 1990 (Cth) be amended to introduce descriptive support requirements, including that the whole scope of the claimed invention be enabled and that the description provide sufficient information to allow the skilled addressee to perform the invention without undue experimentation.
#10 the Patents Act 1990 (Cth) be amended to provide that an invention will satisfy the requirement of 'usefulness' in section 18(1) only in such cases as a patent application discloses a 'specific, substantial and credible' use. The Committee recommends that such amendments incorporate recommendations 6-3 to 6-4 from the Genes and Ingenuity report.
#11 the Patents Act 1990 (Cth) be amended to clarify the circumstances in which the Crown use provisions may be employed; and that the Government develop clear policies for the use of the Crown use provisions. The Committee recommends that the Government adopt recommendations 26-1 to 26-3 from the Genes and Ingenuity (report.
#12 the Government amend the Patents Act 1990 (Cth) to clarify the scope of the 'reasonable requirements of the public' test, taking into account recommendation 27-1 of the ALRC's Genes and ingenuity report. The Committee recommends that the Government review the operation of the competition based test for the grant of a compulsory licence, with particular reference to its interaction with the Trade Practices Act 1974 (Cth).
#13 the Patents Act 1990 (Cth) be amended to include a broad research exemption.
14 to assist courts and patent examiners with the interpretation and application of the Patents Act 1990, the Government consider amending the Act to include anti-avoidance provisions.
#15 to assist courts and patent examiners with the interpretation and application of the Patents Act 1990 (Cth), consideration be given to Government amending the Act to include objects provisions.
#16 the Government establish a patent audit committee.
the Report fails to address the very issue which triggered this inquiry in the first place – gene patents.In contrast Senator Boyce indicates that -
Unfortunately, while the Report states that the Bill introduced into the Senate to ban gene patents is providing a "much-needed opportunity for the arguments and questions around the impacts and effectiveness of an express prohibition on gene patents to be considered" (para 4.135), we are of the view that the evidence presented to this Committee is sufficient to support the call for the implementation of such a ban. The time has come, after more than two years, for action. More talk, which is what this Report suggests as "much-needed" we believe will simply delay necessary action to prohibit gene patents.
I remain very concerned that any changes in one part of patent law may have unintended consequences across a system which has underpinned most technological and industrial advances for centuries.
No changes should be made to patent law without the expert advice of organisations such as IP Australia and the Australian Law Reform Commission.
